Ionoplasm (Solution) Instructions for Use
Marketing Authorization Holder
IST-Pharm, LLC (Russia)
Manufactured By
IST-Pharm, LLC (Russia)
Or
Pharmasintez-Tyumen, LLC (Russia)
ATC Code
B05BB01 (Electrolytes)
Dosage Form
| Ionoplasm | Solution for infusion: bottles 250 mL or 500 mL |
Dosage Form, Packaging, and Composition
Solution for infusion transparent, from colorless to brownish-yellow.
| 1 ml | |
| Potassium chloride | 0.37 mg |
| Magnesium chloride hexahydrate | 0.3 mg |
| Sodium acetate trihydrate | 3.68 mg |
| Sodium gluconate | 5.02 mg |
| Sodium chloride | 5.26 mg |
| Ionic composition: sodium 140 mmol/l (mEq/l) potassium 5 mmol/l (mEq/l) magnesium 1.5 mmol/l (3 mEq/l) chloride 98 mmol/l (mEq/l) acetate 27 mmol/l (mEq/l) gluconate 23 mmol/l (mEq/l) Theoretical osmolarity 295 mOsm/l PH 6.5-8.0 |
|
Excipients : hydrochloric acid solution 1 M or sodium hydroxide solution 1 M – to pH 6.5-8.0, water for injection – up to 1 ml.
250 ml – polyethylene bottles (1) – cardboard boxes.
500 ml – polyethylene bottles (1) – cardboard boxes.
Clinical-Pharmacological Group
Drug for rehydration and detoxification for parenteral use
Pharmacotherapeutic Group
Electrolyte balance restoring agent
Pharmacological Action
A means for rehydration and detoxification. It corrects the acid-base state, replenishes the deficiency of fluid and electrolytes, enhances diuresis, has an antiplatelet property, reduces metabolic acidosis, improves microcirculation, and has a detoxifying, anti-shock effect.
Indications
As a component of infusion therapy as part of complex treatment in adults and children: shock; thermal injury; acute blood loss; hypotonic and isotonic forms of hypohydration and metabolic acidosis in severely ill patients; for the correction of water-salt balance in acute diffuse peritonitis and intestinal obstruction; patients with intestinal fistulas; decompensation of electrolyte disorders; patients with acute intestinal infections; dehydration; metabolic acidosis.
The volemic effect is short-lived; in the treatment of severe hypovolemia, a combination with colloidal solutions, as well as blood and its components, is recommended.
ICD codes
| ICD-10 code | Indication |
| A00 | Cholera |
| A03 | Shigellosis |
| A04 | Other bacterial intestinal infections |
| A05 | Other bacterial food poisonings, not elsewhere classified |
| A08 | Viral and other specified intestinal infections |
| A09 | Other and unspecified gastroenteritis and colitis of infectious origin |
| E86 | Volume depletion (including dehydration, hypovolemia) |
| E87.2 | Acidosis |
| K56.6 | Other and unspecified intestinal obstruction |
| K63.2 | Fistula of intestine |
| K65.0 | Acute peritonitis (including abscess) |
| R57.1 | Hypovolemic shock |
| R57.2 | Septic shock |
| R57.8 | Other types of shock |
| R58 | Hemorrhage, not elsewhere classified |
| T30 | Burns and corrosions of unspecified body region |
| T79.4 | Traumatic shock |
| ICD-11 code | Indication |
| 1A00 | Cholera |
| 1A01 | Intestinal infection caused by other Vibrio species |
| 1A02 | Intestinal infections due to Shigella |
| 1A03.Z | Intestinal infections caused by Escherichia coli, unspecified |
| 1A0Z | Bacterial intestinal infections, unspecified |
| 1A1Z | Bacterial foodborne intoxications, unspecified |
| 1A2Z | Viral intestinal infections, unspecified |
| 1A40.Z | Infectious gastroenteritis or colitis, unspecified |
| 1G41 | Sepsis with septic shock |
| 5C70.Z | Decrease of volume of fluid [hypovolemia], unspecified |
| 5C73.Z | Acidosis, unspecified |
| DA91.Z | Unspecified obstruction of small intestine |
| DA92.0 | Fistula of small intestine |
| DB30.Z | Unspecified obstruction of large intestine |
| DB31.0 | Fistula of large intestine |
| DC50.0 | Primary peritonitis |
| DC50.2 | Peritoneal abscess |
| DC50.Z | Peritonitis, unspecified |
| DE2Z | Diseases of the digestive system, unspecified |
| ME24.1 | Fistula of digestive system |
| MG27 | Hemorrhage, not elsewhere classified |
| MG40.1 | Hypovolemic shock |
| MG40.Z | Shock, unspecified |
| NE11 | Burn of unspecified body region |
| NF0A.4 | Traumatic shock, not elsewhere classified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
IV, the dose depends on the age, body weight and condition of the patient.
In severe forms of diseases – IV bolus, in mild forms – IV drip.
Before administration, the solution is heated to body temperature. The initial dose is 5-10 drops, then a break is taken for 2-3 minutes to assess the results of the biological test, after which 30 drops are administered, followed by a break for 2-3 minutes. In the absence of individual intolerance, they switch to drip or jet administration in quantities necessary to restore the volume of fluid lost with feces, vomiting, urine, and sweat.
Adverse Reactions
Possible anaphylactoid reactions (tachycardia, decreased blood pressure, itching, skin hyperemia, shortness of breath, hyperthermia), hyperkalemia; allergic reactions.
Contraindications
Hyperkalemia; chronic renal failure; pulmonary edema; chronic heart failure grade II-III; arterial hypertension; hypertensive crisis; traumatic brain injury with increased intracranial pressure.
With caution
Diabetes mellitus (for solution with dextrose).
Use in Renal Impairment
Contraindication — chronic renal failure.
Special Precautions
In patients with renal, cardiac, or hepatic insufficiency, it is necessary to monitor the level of electrolytes in the plasma.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical Disclaimer